Frank Yiannas: FDA’s reorganization to create Human Foods Program is only a ‘first step’ to enhanced safety

But the reorganization is “just a first step” towards the agency’s ultimate goal to be a more integrated body that can more effectively and efficiently oversee the safety and regulation of the US food supply, cautioned Frank Yiannas, former FDA deputy commissioner of food policy and response turned consultant.

“I have been a strong proponent that FDA had to operate as a more integrated body. But having said that, I want to put this in perspective,” he told attendees gathered in Washington at Prime Label Consultants’ 2024 Food Label Conference.

Recalling a famous quote that likens reorganization to a “wonderful method for creating the illusion of progress while producing confusion, inefficiency and demoralization,” Yiannas called on FDA to be transparent in the reorganization’s progress and impact to protect against the perception it is little more than smoke and mirrors.

“We need transparent metrics to tell us if the reorg is working, because we are all going to celebrate the reorg took place, but how do we know if it is working?” he said, suggesting the metrics include faster and more approvals, more efficient inspections, reduced recalls and measurable improvements in public health outcomes.

“I really call on all stakeholders, including FDA and Congress, to say, ‘Let’s put some management in place and with the measurements to help you manage things right. Without measures, there is no accountability.”

He also urged FDA and stakeholders to proactively protect the reorg from the ill fate that a McKinsey & Co. survey ​found most reorgs suffer. According to the survey, more than 80% of reorganizations fail to deliver the hoped-for value within the parameters and time allotted and 10% cause “real damage” to the company.

Yiannas said that many reorganizations fail because they do not align with the vision or strategy and people do not change how they are working, along with many other reasons.

These are notable threats given that a primary driver for FDA’s reorg was to repair a broken culture in which staff loyalties were divided among leaders who often had conflicting or different priorities.

Next steps: Set an agenda and embrace new approaches​

Saying that he was “not trying to be critical of the reorganization,” Yiannas reiterated that the reorg is a first step, after which, he said, there are many more the agency needs to take to ensure its success.

These include setting a clear agenda, which he praised FDA for already making public on its website.

“I am pleased to see that the FDA is now starting to actually publish the regulatory agenda. … It is on their website: what are the regulations they expect to move this year? And what are the guidance documents?” he said.

While he characterized the agenda​ as “modest,” he also acknowledged “there is a lot of work” that will go into the items, which include reducing sodium across the food supply, supporting healthy habits early, updating and making labeling more accessible, educating consumers and supporting innovation.

‘These modern times are going to require us to work differently’​

To speed progress towards FDA’s goals, Yiannas encouraged the agency to “do things differently.”

He explained the agency has tried to improve food safety and oversight for years by increasing the number and frequency of inspections and tests, but food safety recalls and contamination continue to abound.

“These modern times are going to require us to work differently,” he said.

For example, he said, the agency needs to be more collaborative and embrace data sharing.

“Collaboration is no longer having meetings and talking to each other and sharing best practices. We are living in the digital age. To me, collaboration … increasingly involves data sharing, because some of the challenges that we are trying to solve today are different than what we tried to solve in years past. And you are not going to solve them by just getting rid of talking. Data sharing will be critical,” he said, adding by sharing “we all get smarter together.”